Influence of Triflusal on Cognitive Functions in Subjects Under Chronic Stress

NCT02904109 | Completed Phase 2

• 1 other identifier: 2016DR2116
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effects of the eNOS activating agent triflusal on episodic memory and cognitive functions in participants under chronic stress.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change in performance in episodic memory task as assessed by a verbal memory task between placebo and verum at two different time points. Verbal task as described in ( de Quervain, Henke et al. 2003). Number of correctly *

  Verbal task as described in ( de Quervain, Henke et al. 2003). Number of correctly remembered words is counted.

  Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.

Secondary Outcomes (7)

• Change in performance in working memory task between placebo and verum at two different time points.

  Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.

• Change in performance in episodic memory task between placebo and verum at two different time points.

  Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.

• Change in performance in a memory game between placebo and verum at two different time points.

  Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.

• Change in subjective memory impairment between placebo and verum

  20 min before last medication of each placebo and verum

• Mood state changes between placebo and verum at two different time points.

  Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.

Study Arms (2)

Verum/Placebo

EXPERIMENTAL

This group will start with triflusal and after washout will receive placebo.

Drug: Triflusal; Drug: Placebo

Placebo/Verum

EXPERIMENTAL

This group will start with placebo and will receive triflusal after washout.

Drug: Triflusal; Drug: Placebo

Interventions

Triflusal DRUG

Once daily oral administration of 600 mg triflusal Disgren® for 8 days.

Also known as: Disgren®

Placebo/Verum; Verum/Placebo

Placebo DRUG

Once daily oral administration of placebo mannitol for 8 days.

Also known as: mannitol

Placebo/Verum; Verum/Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• male or female
• normotensive (BP between 90/60mmHg and 140/90mmHg)
• BMI between 19 and 29 kg/m2
• aged between 18 and 40 years
• experiencing chronic stress for at least 1 month (TICS sum score in subscale "overextension at work" \>= 55)
• native or fluent German-speaking
• able and willing to give written informed consent as documented by signature and comply with the requirements of the study protocol
• willing to donate saliva sample for DNA-analysis
• female: willing to perform a pregnancy test at the beginning of both medication phase and at the follow-up visit.

You may not qualify if:

• Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to salicylates and other NSAIDs
• acute or chronic psychiatric disorder (e.g. major depression, psychoses, somatoform disorder, suicidal tendency) except symptoms of chronic stress
• cognitive impairment as detected by DemTect
• concomitant acute or chronic disease state (e.g. renal failure, hepatic dysfunction, cardiovascular disease, acute infections etc.)
• women who are pregnant or breast feeding
• intention to become pregnant during the course of the study
• lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases
• active peptic ulcer or antecedents or complicated peptic ulcer or history of peptic ulcer. Any other active pathological bleeding
• history of coagulation abnormality
• thyroid problems
• pathological ECG
• known or suspected non-compliance, drug or alcohol abuse
• inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
• participation in another study with investigational drug within the 30 days preceding -

Sponsors & Collaborators

• Prof. Dominique de Quervain, MD: lead

Study Sites (1)

University of Basel, Division of Cognitive Neuroscience

Basel, Basel, 4055, Switzerland

Location

MeSH Terms

Interventions

triflusal; Mannitol

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: September 16, 2016
• Study Start: September 13, 2016
• Primary Completion: February 21, 2017
• Study Completion: February 28, 2017
• Last Updated: March 1, 2017

Record last verified: 2017-02

Locations

CH (1)